Category: Ethics in research. These pages describe some of the ethical principles in the conduct of research as well as information on how an Institutional Review Board (IRB) or other research ethics board evaluates research proposals. are arranged by date with the most recent entries at the top. You can find the theme and closely related categories and other resources at the bottom of this page.
Stats: Why we need case studies of research ethics in graphic novel format (April 3, 2008). I was asked to provide some justification for a project I am working on, case studies in research ethics using a graphic novel format. Here is what I wrote.
Stats: Illustrations for a case study of the TGN 1412 trial (October 12, 2007). I am working with a graphic artist to produce some illustrations to help explain what happened during the disastrous TGN1412 trial. The general structure of these illustrations are not quite set in stone, but here are my initial thoughts.
Stats: Conflict of interest in the Wakefield MMR study (July 26, 2007). An interesting case study in conflict of interest (perhaps a bit too complex to be described fairly in this brief weblog entry) involves a controversial paper. The lead author of this paper, Wakefield A; Murch S, Anthony A, Linnell J, Casson D, Malik M, Berelowitz M, Dhillon A, Thomson M, Harvey P, Valentine A, Davies S, Walker-Smith J (February 28 1998). Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children 637-641. The Lancet - Vol. 351, Issue 9103. DOI:10.1016/S0140-6736(97)11096-0, is Andrew Wakefield. Dr. Wakefield has alleged on the basis of twelve children referred to his clinic that there was a link between the MMR vaccine and the development of autism.
Stats: Illustrated case studies of research ethics and research fraud (June 11, 2007). I've written a fair number of case studies involving research ethics and research fraud for the Chance Wiki. I want to take some of this material and produce some web pages with nice illustrations that will bring these cases to life and make them more memorable. This may eventually lead to a book, but that is quite a way down the road.
Stats: IRB review of studies with methodological flaws (April 10, 2007). Someone (AK) wrote into the IRBForum asking about how the IRB should do when they discover methodological flaws in the proposed research. If everything else is in order (e.g., appropriate consent forms), is the IRB still justified in asking that the flaw be fixed prior to approval of the research?
Stats: IRB review of a pilot study (March 26, 2007). Dear Professor Mean: I am the new chair of the IRB at a county hospital. Many of the studies we review are pilot studies with small samples. I have been trying to locate criteria for the scientific review of pilot studies, but have not found a consensus in the literature that I have seen. Is a pilot study merely a "dry run" of the procedures that will be used in a later, larger-scale study? Or, is it reasonable for the IRB to demand that the investigator provide specific criteria for determining whether the pilot has been a success? And, should the IRB furthermore demand that specific hypotheses be formulated? My impression is that many investigators declare their studies to be pilots in order to avoid more rigorous scrutiny of their proposals.
Stats: Academic freedom and the Institutional Review Board (October 17, 2006). The American Association of University Professors (AAUP) recently published a report, Research on Human Subjects: Academic freedom and the Institutional Review Board. This report is sharply critical of Institutional Review Boards (IRBs) and cites several anecdotes of abuse and misuse of the review process by IRBs.
Stats: Special issues for research involving children (September 15, 2006). Research is difficult enough, but it becomes more difficult when the research involves children. The issues that you need to consider are physiologic, ethical, and statistical.
Stats: Questions a volunteer should ask before participating in a clinical trial (July 18, 2006). A regular contributor to the IRBForum (MG), wrote a nice list of questions that a volunteer should ask before they decide to participate in a clinical trial.
Stats: Ethics and the fiduciary obligation (June 19, 2006). One of the regular contributors to the IRBForum noted the publication of the following article: Miller PB, Weijer C. Fiduciary obligation in clinical research. Journal of Law, Medicine & Ethics 2006; 34(2): 424-440. which is too recently published for me to find a good PubMed record. Another contributor pointed out a competing viewpoint: Morreim EH. The clinical investigator as fiduciary: Discarding a misguided idea. Journal of Law, Medicine & Ethics 2005; 33(3): 586-598. and E. Haavi Morreim, Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities, 32 J.L. Med & Eth 474, 477 (2004). These articles caught my eye because a lot of discussion about ethical practice refers to the fiduciary duty of a physician for his/her patients.
Stats: Waiver of informed consent (March 3, 2006). Most prospective research studies require the informed consent of the participants, so it is interesting to find exceptions to this rule. I found a recent publication that has a common sense reason to bypass informed consent: TREC-Rio trial: a randomised controlled trial for rapid tranquillisation for agitated patients in emergency psychiatric rooms [ISRCTN44153243]. G. Huf, E. S. Coutinho, C. E. Adams. BMC Psychiatry 2002: 2(1); 11..
Stats: Self experimentation (September 13, 2005). Stephen Dubner and Steven D. Levitt, authors of the hot selling book, Freakonomics: A Rogue Economist Explores the Hidden Side of Everything, have a regular column in the New York Times Magazine. In the September 11, 2005 issue, the article "Does the Truth Lie Within" discusses self-experimentation.
Stats: IRBs and scientific validity (August 12, 2005). One of the regular posters on the edstat-l mailing list shared a comment that is commonly held among many of the people I have talked to. IRB's should NOT be in the business of trying to make studies good. IRBs are not sufficiently experts in all the different kinds of proposals that come across their desks. They are there to make sure that the principles of informed consent and lack of coercion ... have been faithfully taken care of. This comment is a reaction to the tendency of some IRBs to nitpick. While I am somewhat sympathetic to overly intrusive reviews that we all have to endure, it is important to remember the underlying rationale for IRB review of scientific validity.
Stats: Ethical principles for Complementary and Alternative Medicine Research (January 24, 2005). The National Academies Press, has a new publication available, Complementary and Alternative Medicine in the United States. This publication was prepared by the U.S. Institute of Medicine at the request of the National Institutes of Health and the Agency for Healthcare Research and Quality. You have to purchase the PDF files that constitute the book, but you can also browse through the contents and view a free executive summary. One chapter title that immediately caught my attention was "An Ethical Framework for CAM Research, Practice, and Policy." The authors list five ethical principles that provide the foundation for their recommendations.
Stats: Monetary incentives (January 3, 2005). Someone on the IRBForum asked about monetary incentives in research. This is a controversial area (see the OHRP website, Foy 1998, Sugarman 2004, Young 2001), and especially controversial for studies involving children (Fernhoff 2002) but monetary incentives do indeed help improve recruitment, at least for a postal survey (Edwards 2002; Smeeth 2002).
Stats: Submitting a research protocol to the IRB (July 29, 2004). I usually just watch and advise as others submit research protocols to our Institutional Review Board (IRB). But now I might end up having to submit one myself. I want to perform a secondary data analysis on a data set that was collected several years ago. It should be an educational experience. If I do learn anything valuable, I'll put it on this weblog.
Stats: Why informed consent is so important (May 2, 2003). To understand why researchers today must obtain informed consent from their patients before they subject them to experiments, you need to understand some of the previous abuses of medical research.
Stats: Getting IRB approval for your research (October 9, 2002). Dear Professor Mean: I am submitting a proposal to our Institutional Review Board. Is there anything you can do to help me get IRB approval? --Terrified Terri
Theme and closely related categories:
- Theme: Planning a research study.
- Category: Conflict of interest
- Category: Fraud in research
- Category: Privacy in research
- Debating how to do ethical research in developing countries
- Engagement of Institutions in Research
- Bioethics Issues. Description: This webpage lists resources covering many controversial research experiments.
- The History of Human Medical Experimentation in the United States Description: This webpage provides a detailed and harshly critical timeline of medical research. The author has an axe to grind against traditional medicine and big drug companies, but the descriptions are still valuable.
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This webpage was written by Steve Simon on 2007-08-06, edited by Steve Simon, and was last modified on 2008-07-08. Send feedback to ssimon at cmh dot edu or click on the email link at the top of the page.